Organic salts of N,N'-diacetyl cystine

Abstract

New crystalline organic salts of N,N'-diacetyl cystine with immunomodulating effect, processes for their preparation, pharmaceutical compositions containing them and methods of their pharmacological use.

Claims

1. A process for preparing a salt of an organic base and N,N'-diacetylcystine having the formula ##STR2## or a hydrate or a solvate thereof, whereby the salt in solid form has a combination of nonhygroscopicity and crystallinity, which renders it favorable for inhalation in solid form or other dry formulations, which process comprises the steps of

(a) forming a salt of N-acetylcysteine and an organic base, R.sup.+ or R.sup.2+, selected from lysinium, ethylenediaminium, N,N'-dibenzylethylenediaminium, N-benzyl-2-phenylethylaminium and 1-adamantanaminium,

(b) oxidizing the N-acetylcysteine salt and

(c) precipitating and isolating the resultant N,N'-diacetylcystine salt.

2. The process according to claim 1, wherein the organic base is lysinium.

3. The process according claim 1 or 2, wherein the N,N'-diacetylcystine is in the form of its D-isomer, L-isomer, meso-form or racemic mixture.